---
kind: "section"
citation: "21 U.S.C. § 399a"
title: "21"
title_heading: "Food and Drugs"
number: "399a"
heading: "Office of the Chief Scientist"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/399a"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter X — Miscellaneous"
---

# §399a. Office of the Chief Scientist

- (a) **Establishment; appointment—** The [Secretary](/usc/21/321.md?p=d) shall establish within the Office of the [Commissioner](/usc/21/321.md?p=ee) an office to be known as the Office of the Chief Scientist. The [Secretary](/usc/21/321.md?p=d) shall appoint a Chief Scientist to lead such Office.
- (b) **Duties of the Office—** The Office of the Chief Scientist shall—
  - (1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration;
  - (2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the [Commissioner](/usc/21/321.md?p=ee), and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration;
  - (3) develop and advocate for a budget to support intramural research;
  - (4) develop a peer review process by which intramural research can be evaluated;
  - (5) identify and solicit intramural research proposals from across the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration through an advisory board composed of employees of the Administration that shall include—
    - (A) representatives of each of the centers and the science-based offices within the Office of the [Commissioner](/usc/21/321.md?p=ee); and
    - (B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and
  - (6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

## Source credit

(June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)